Cornered (18 page)

Chaplin's crossbreeding experiments showed that plants could be developed with a nicotine content varying from 0.2 percent to 4.0 percent by weight. He had produced plants with a nicotine content up to 6 percent, but they were weak and invariably blew over in a strong wind. Chaplin used to tell the story of his high-nicotine plants at tobacco conferences he attended and this was how Brown & Williamson learned of Yl. The company obtained sample seeds from Chaplin and rented Lloyd Jones's farm to grow them. Chaplin, who had just retired from the Agriculture Department, was taken on by B&W as a consultant.

He told the FDA what happened after Lloyd Vernon Jones had succeeded in growing the plant. In 1983, B&W took the plant to a genetic engineering lab, DNA Plant Technology, or DNAP, then based in New Jersey. B&W wanted a male sterile version of the plant, a procedure that effectively prevents commercial competitors from stealing and reproducing the new variety. In order to protect their precious Yl, Brown & Williamson eventually filed an application for a Plant Variety Protection Certificate in February 1991. In September of that year, the company filed U.S. patent application No. 761,312 in the Patent Office in Washington, D.C. A year later, they also filed a patent in Brazil, where the company intended to grow the first batch of Yl. Southern Brazil has excellent soil and growing conditions for tobacco, and the major tobacco companies grow substantial quantities of their product there.

Growing Y1 offshore—in Brazil—and then bringing it back into the country would also be a way of circumventing the gentlemen's agreement among the tobacco companies not to grow tobacco with more than agreed-upon levels of nicotine. The question the FDA wanted answered was, Had B&W used Y1 commercially? If they had, the FDA would have powerful evidence that the company was manipulating the level of nicotine in its cigarettes. Moreover, instead of putting it there for taste and flavor, as the companies asserted, they were including it at a certain level to assure the needed pharmacological action on the smoker's brain.

The FDA investigators found Janis Bravo, one of the names on the Brazilian patent. She worked for the genetic engineering company DNAP. Bravo cooperated with the FDA agents. She told them how she had worked on Y1 and was certain seeds had been shipped to Brazil on more than one occasion, but she did not know the quantity; nor did she know whether the seeds were intended for a commercial operation. She knew of one seed shipment that weighed ten pounds, or enough to grow 2 million pounds of tobacco. Both Chaplin and Bravo told the FDA they had actually seen Y1 growing in Brazil in the 1980s. The farms were under contract to Souza Cruz Overseas, another BAT subsidiary.

But had any Y1 been shipped back into the United States for commercial use? Kessler hired a former U.S. Customs official and sent him on a painstaking computer search of the U.S. Customs imports database. When that exercise turned up nothing, a separate manual search was made of customs receipts of shipments from Brazil. “It was really like looking for a needle in a haystack,” Kessler would say later.

A week after the Brazilian search, the FDA investigators found what they were looking for: two invoices showing that more than half a million pounds of Y1 had been shipped from Souza Cruz Overseas to Brown & Williamson in Kentucky in September 1992. The shipments had come via the Souza Cruz offices in the Cayman Islands and did not mention Brazil. The order was entitled “Project Yl.” Still, the FDA did not know if Y1 had been used commercially. DNAP should have known because they had an agreement with B&W whereby they would be paid a royalty if Y1 were used commercially. But the company did not know.

Kessler's inquiry had alerted B&W, of course. The company's attorneys, King & Spalding of Atlanta, sent Kessler an angry letter objecting to the FDA calling on B&W employees without the permission of the company. The letter said B&W “found these contacts extremely disturbing” and urged “that agency inquiries … be made through official channels in a businesslike manner.” The FDA responded that the agency's efforts were justified because of the company's earlier reluctance to cooperate. He reminded B&W of the earlier Macon visit when B&W had not been as forthcoming as they might have been about growing tobacco plant varieties.

B&W requested another meeting. This time the company brought a team of lawyers and executives to FDA headquarters. One of them was Hugh Hardison, who had told the FDA about Chaplin. Now, he repeated his story of getting the seeds from Chaplin and contacting Lloyd Vernon Jones, but he said that his knowledge of the experimental plant ended in the early 1980s. Another B&W official, Drew McMurtry, took up the story, telling the FDA that B&W had four and a half million pounds of Y1 stored in tobacco warehouses in the U.S. He also volunteered that the company had used Y1 in its brands—Richland, Viceroy, and Raleigh—the last mentioned being the favorite, as it happened, of Martha Jones, Lloyd's widow. McMurtry said the company had experimented with Y1 as a “blending tool.”

“What do you mean?” asked the FDA officials.

McMurtry replied that the company was trying to lower the tar and still maintain the nicotine level. The FDA's lead counsel on the Y1 case, Mitch Zeller, said later, “That flies in the face of the industry's assertion, under oath, that they don't design cigarettes for nicotine but only for tar.” As far as the FDA was concerned, the Y1 story was prima facie evidence that Brown & Williamson had manipulated the nicotine content of their cigarettes to keep smokers hooked on the drug.

Kessler returned to the Waxman committee. At the end of June, he said that his earlier testimony had been “suggestive” of the industry's control and manipulation of nicotine. Now, he was ready to present “actual instances” and he told his detective story about Yl, adding the strange final action B&W had taken. He told about B&W's application for a patent for the Y1 plant and also for a Plant Variety Protection Certificate. The company had also deposited samples of Y1 seed with the National Seed Storage Laboratory in Fort Collins, Colorado. But the plant certificate application had been withdrawn on March 14, just eleven days before Kessler's first appearance before the Waxman committee. The company had also removed the Y1 seeds it had deposited in Colorado. The U.S. patent application had been rejected at first but the company had filed an appeal on February 25, 1994, the date of Kessler's original letter about nicotine manipulation. Two weeks later, before receiving a ruling on the patent application appeal, B&W abandoned the patent altogether, withdrawing their application. Although he had no hard evidence that the dates were anything more than coincidental, Kessler was hinting there was something fishy about the whole affair.

To reinforce his nicotine-manipulation charge, Kessler also introduced another piece of the puzzle. He had learned from his whistle-blowers how the tobacco companies “free up” more nicotine for the smoker by the addition of ammonia to the tobacco blend. In April, under pressure from antismoking forces, the cigarette companies had released a list of 599 ingredients added to tobacco. Among the chemicals were several ammonia compounds. Ammonia, Kessler had discovered, had multiple uses. It strengthens the adhesiveness of the tobacco on the production line before it is chopped up and made into cigarettes. It also reacts with sugars to produce different flavors. But most important to Kessler's inquiry was the fact that ammonia can affect the delivery of nicotine. When added to a tobacco blend, ammonia reacts with nicotine salts to free nicotine. Kessler read from a tobacco company blender's handbook, which said, “As we know, extractable nicotine contributes to impact [nicotine effect] in cigarette smoke and this is how ammonia can act as an impact booster … this means … a cigarette incorporating ammonia technology will deliver more flavor compounds, including nicotine, into smoke than one without it.” He wouldn't name the company that had produced the handbook, but it was from Brown & Williamson, courtesy of “Research.”

Kessler concluded, “Why spend a decade developing through genetic breeding high-nicotine tobacco and adding it to cigarettes if you are not interested in controlling and manipulating nicotine? Why focus on the enhanced delivery of nicotine to the smoker by chemical manipulation, if you are not interested in controlling and manipulating nicotine?”

B&W's chief executive, Thomas Sandefur, denied there had been anything sinister in the growing of Yl. There was never any secret about it, he claimed. The FDA's story about his company holding back information was “grossly misleading and unfair.” He accused Kessler of “grandstanding” and also complained about Merrell Williams's theft of documents. It was like being back in the bad old days of McCarthyism, he said “when blacklisting and vilification of honest and reasonable people were sanctioned for the sake of advancing a political agenda.”

But what had Kessler really achieved? Y1 was a great detective story and the way Kessler's team had pursued it, delving into libraries and patent records and toughing it out with tobacco company lawyers, was certainly the most strenuous effort ever made by the FDA to address the public health problem of smoking-related illnesses. The way Kessler himself had presented it to Congress, aided and abetted by Waxman, Wyden, and Synar, was masterful antitobacco agitprop. But there was a lot more work to be done. If the FDA was ever going to regulate tobacco, Kessler had to declare nicotine an addictive drug, which was something the FDA had never done. And he had to issue a set of rules to bring the industry under his jurisdiction. He could only do that with consent of the White House, and President Clinton was about to face a re-election campaign. The president's pollsters had told him he needed to win the tobacco states to be assured of victory. To get to the president, Kessler had to convince the pollsters that the issue could bring a bonanza of public support. There was a lot of work still to do.

6

THE SWEET SMELL OF GAIN

… The sweet smell of gain makes the smell of tobacco less perceptible and less offensive.…

—
B. Ramazzini, De Morbis Artificum

 

A
NY LAWYER
who challenges the big tobacco companies in court inevitably encounters the ghost of a domineering biologist named Clarence Cook Little. In a long scientific career in cancer research, mostly as an administrator, he became one of the world's most famous breeders of mice for laboratory experiments.

In his “mouse house,” as the lab at Bar Harbor on the coast of Maine was affectionately known, some of Dr. Little's mice proved highly resistant to cancer and rarely developed the disease, while other groups were so prone that almost all the mice had cancer in one form or another. In the 1940s, when most scientists were looking for cancer-causing agents in the array of complex, man-made compounds then being dispersed into the environment, Little advocated what was known as a “constitutional hypothesis”; that is to say, it was a person's genetic makeup, perhaps even a distorted or damaged gene, that was probably the basic cause of cancer. The damaged gene allowed the abnormal and, in the end, unrestrained growth of cells.

This was not an original thought. From the earliest days of cancer research, scientists expected to find that some people were more prone than others to the disease simply because of their genes, and indeed this notion has been borne out in modern research. But there was one form of cancer that scientists were beginning to believe might have something to do with smoking tobacco, a particularly insidious type which attacked the bronchial passages and the lungs.

There was good evidence to support this notion. For example, the disease was extremely rare in Iceland, where smoking was not introduced until the '30s, and in Norway, where smoking had not been widespread. On the other hand, the disease was particularly common in Finland and Austria, two countries where people had smoked for years. In fact, researchers could not find any evidence of a population that did not smoke but had a high incidence of this type of lung cancer. Nor could they find a low incidence of lung cancer in populations that had smoked for a long time. In other words, there was no evidence to support the suggestion that one group of people could regard themselves as immune to developing lung cancer from smoking.

As the statistical evidence grew for the link between lung cancer and smoking, Dr. Little refused to believe in tobacco's causality and, instead, remained wedded to the “constitutional hypothesis.” Some people get it and some don't, depending on their genetic makeup, he maintained. In the early 1950s, when researchers actually found a statistical link between smoking and lung cancer, Dr. Little sided with skeptics who argued that one factor, smoking, could not be a cause, and many factors probably should be considered, including heredity, sex, hormones, diet, and vitamins. Dr. Little's position called on the scientific community to unlock the secrets of the human cell before accepting any link between smoking and cancer. Needless to say, the tobacco companies became very interested in his opinions.

*   *   *

I
N
1953, the tobacco companies faced the first real threat to their livelihood. A young epidemiologist, Ernst Wynder, the son of a German Jewish doctor who had fled the Nazis, had been testing so-called tars from cigarette smoke on mice at the Memorial Sloan-Kettering Cancer Center in New York. The mice he used in the experiments were selected at random from Little's “mouse house” in Maine. He shaved the hairs from the backs of eighty-six mice with an electric razor and painted the skin with the sticky brown substance he obtained by condensing the smoke from Lucky Strike cigarettes. At the end of a year, sixty-two of the painted mice had survived and 58 percent of them had developed cancerous tumors. Wynder concluded that “the suspected human carcinogen has thus been proven to be a carcinogen for a laboratory animal.” The experiment had provided “a working tool which may enable us to identify and isolate the carcinogenic agent(s) within the tars.” Skeptics remained, of course, some complaining Wynder's “tar” mix was too highly concentrated and therefore not comparable to the smoke inhaled by humans. Others said that cancer experiments on mice were irrelevant to humans. But for the first time doctors generally began to take the link between smoking and lung cancer seriously.